Name: Predicase
Price: 199 USD

K-number	K090409
Device name	BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
Applicant	Bio-Rad Laboratories
Product code	MXJ
Device class	Class II
Decision date	May 8, 2009
Decision	Substantially Equivalent
Regulation	866.3305

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Source

View the full FDA submission: accessdata.fda.gov

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BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

Everything you need for a 510(k) submission. Nothing you don't.